FDA.reportPublic FDA data

Premium Rubber Helmet Condoms

Primary DI
00850016109149
Brand
Premium Rubber Helmet Condoms
Company
Scutagli, LLC
Model
RH10024
Device description
Premium Rubber Helmet Condoms Aegis 49 Lubricated Latex Condoms - 24 Bulk Count
Published
2023-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994095000LATEX CONDOMThai Nippon Rubber Industry Co., Ltd.2000-01-18HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016109149PrimaryGS10
00850016109156Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016109149008500161091498500161091490850016109149
00850016109156008500161091568500161091560850016109156

GMDN Terms#

Term, Definition table
TermDefinition
Basic male condom, Hevea-latexA Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
720-351-5879emukai@scutagli.com

Regulatory Flags#

DUNS number
078668294
Device count
24
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016109705Premium Rubber Helmet CondomsSCLF-520502023-11-09
00850016109712Premium Rubber Helmet CondomsSCLF-520502023-11-09
00850016109156Premium Rubber Helmet CondomsRH100242023-08-25
00850016109095Premium Rubber Helmet CondomsRH100502022-09-16
00850016109071Premium Rubber Helmet CondomsRH100062022-09-13
00850016109088Premium Rubber Helmet CondomsRH100062022-09-13
00850016109019Premium Rubber Helmet CondomsRH101002021-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06977708239725ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
06977708239732ZIOXXShaoguan Regenex Pharmaceutical Co., Ltd.HIS2026-08-26
00860014891533HUNKHunk World, Inc.HIS2026-08-19
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